Principal Statistical Progammer

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Responsibilities: 

• Lead the development and validation of statistical programs to produce high-quality deliverables for in-house and outsourced projects, ensuring compliance with company and regulatory requirements.
• Support ISS/ISE analyses for NDA submissions.
• Assist with project work to ensure timely, high-quality delivery across studies.
• Create and review programming plans and specifications for datasets and TLFs. Requires advanced knowledge of CDISC standards, including SDTM and ADaM models, with experience in implementing these models.
• Review documents produced by biometric functions, such as SAP, CRFs, data review plans, and data transfer agreements.
• Review and validate deliverables produced by CROs, including SDTM, ADaM, and TLFs, and provide solutions to issues raised by CROs.
• Review e-submission datasets and data documentation, including aCRFs, reviewer guides, define.xml documents, and programs to ensure all files meet submission requirements.
• Develop macros to support study and project activities, improving overall efficiency and capacity of the programming function.
• Stay current with ICH guidelines and maintain advanced knowledge of submission requirements and standards.
• Support the preparation of clinical study reports, regulatory submissions, annual DSURs, and safety reports for multiple studies.
• Effectively communicate within the project team environment, across departments, and with external collaborators.

The Ideal Candidate

• Expert-level SAS programmer with experience delivering complex programming assignments and analyses. Proficient in developing original code, including macros, as well as modifying existing code.
•  Advanced knowledge and extensive hands-on experience with CDISC standards, such as CDASH, SDTM, and ADaM.
• Experience in the drug development process and working with CROs.
• Experience with FDA/EMEA/CDE filings.
• Strong interpersonal and effective communication skills (oral and written).
• Thorough attention to detail and consistency.

Education Requirement

• Bachelor’s degree or equivalent education, preferably in a computational or biological science, with a minimum of 8 years of directly related experience in a drug development environment.
• Or a Master’s degree with a minimum of 6 years of related experience.

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